The following data is part of a premarket notification filed by Airinspace B.v. with the FDA for Plasmair, Model T2006.
| Device ID | K070722 |
| 510k Number | K070722 |
| Device Name: | PLASMAIR, MODEL T2006 |
| Classification | Cleaner, Air, Medical Recirculating |
| Applicant | AIRINSPACE B.V. 43795 LEE MILL SQUARE Leesburg, VA 20176 |
| Contact | Wade Tetsuka |
| Correspondent | Wade Tetsuka AIRINSPACE B.V. 43795 LEE MILL SQUARE Leesburg, VA 20176 |
| Product Code | FRF |
| CFR Regulation Number | 880.5045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-15 |
| Decision Date | 2007-12-14 |
| Summary: | summary |